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About the Role

This role leads and supports the development of maintenance strategies, goals, and metrics to ensure an efficient and effective maintenance organization. The manager oversees the maintenance department, providing technical, project management, and troubleshooting support for facilities, utilities, and process equipment, while acting as a technical expert and point of contact during compliance inspections.

Responsibilities

Leads and supports the development of a Maintenance Vision, Mission, Strategies and Goals.
Supports and maintains maintenance metrics for benchmarking.
Develops improvement strategies based on benchmarking data.
Manages the maintenance department providing technical, project management, emergency response, troubleshooting, and preventative maintenance support.
Acts as a technical expert for equipment or systems, troubleshooting operational issues.
Serves as a point of contact during compliance inspections.
Provides solutions to a variety of technical problems.
Supports the development of department budgets.
Ensures appropriate training for the maintenance organization (cGMPs, technical, SOPs, compliance) and maintains training records.
Oversees the development, revision, review, and approval of maintenance-owned Standard Operating Procedures/Job Plans.
Supports project engineering in the justification, prioritization, and coordination of manufacturing projects.
Provides design assistance based on operational, facilities, and production requirements.
Partners with internal departments to align maintenance operational strategies with compliance commitments.
Maintains an environment promoting maintenance flexibility, consistent practices, and efficient operations.
Supervises direct reports in maintenance and/or utilities operation activities.
Ensures compliance with safety regulations and safety permits.
Contributes to the leadership team and engages in business decision-making from a Quality perspective.
Promotes a safe and harmonious work environment.
Maintains compliance with SOPs, GMPs, and company policies.

Requirements

Projects are completed on time and per documented project plans.
Technicians are well trained, cooperative, work collaboratively, and maintain GMP compliance.
Reports are completed accurately and in a timely manner.
Regulatory visits are planned and executed effectively.
OEE results are analyzed, reported, and improvement plans are communicated and implemented.
Values personal and co-worker competency.
Is receptive to constructive feedback.
Ensures critical documentation, including SOPs, are accurate, updated, codified, used compliantly, and stored appropriately.
Maintains critical parts at all times.
Continuously maintains effective quality and compliance vigilance.
Maintains a safe, healthy, and regulatory-compliant work environment.
Meets departmental standards.
Meets goals established by manager.
Attends work as scheduled.

Skills

Knowledge of general computer functions (Microsoft Office, spreadsheets).
Knowledge and understanding of pharmaceutical manufacturing and production processes.
Knowledge of regulatory and development processes.
Understanding of how regulatory entities approach inspections.
Experience responding to regulatory observations.
Knowledge of regulatory cGMP requirements for pharmaceuticals.
Understanding of regulatory approval processes.
Knowledge of cGMPs and SOPs.
Understanding of regulatory entity inspections requirements.
Knowledge of regulatory guidance documents.
Advanced knowledge of production equipment and supporting systems.
Skill in identifying, analyzing, and controlling hazards significant for product quality and reliability.
Skill in handling multiple projects or tasks simultaneously.
Advanced Problem Safety Sensitivity: ability to recognize safety issues.
Skill in quality and compliance vigilance.
Skill in creating and implementing a document control system.
Ability to inspect the work of others and coach performance.
Ability to apply critical thinking.
Ability to develop a comprehensive maintenance system, including writing policies and SOPs.
Ability to mentor others in writing policies and SOPs.
Ability to effectively articulate and present the company’s maintenance strategy.
Advanced project management skills.
Advanced documentation skills.
Ability to use appropriate training/instructional methods.
Ability to instruct/teach one-on-one.
Ability to trust, develop, maintain, and strengthen partnerships.
Ability to lead by example.
Ability to communicate courteously and professionally.
Ability to work in a fast-paced environment.
Ability to pay close attention to detail.
Ability to coordinate various activities simultaneously.

Location

Onsite

Work Type

Full-time
1st Shift

Experience Level

5+ years managing maintenance technicians and/or engineers

Education Level

Bachelor's degree in engineering or related field from a regionally accredited institution

About the Company

https://www.steri-pharma.com

Equal Opportunity

Notice of Employee Rights, Protections, and Obligations under Labor Law Section 740: https://dol.ny.gov/system/files/documents/2022/02/ls740_1.pdf
EEOC 'Know Your Rights' Poster: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
Employee Rights Under the Polygraph Protection Act: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf